Chronic Kidney DiseasesNCT04211610
Troponin Excretion in Urine in Patients With and Without Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Acute Myocardial Infarction, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
In this study, in order to better understand the mechanism of troponin clearance and the reason for elevated troponin levels in patients with CKD, we aim to evaluate quantitatively the excretion of troponin in the urine in patients with and without CKD, and with and without myocardial injury. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Acute Myocardial Infarction
- What is being tested?
- Blood and urine sampling
- How many people
- 131 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2020to 31 Dec 2023
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be screened at the internal wards, the nephrology ward and clinic, and the intensive cardiac care unit (ICCU) of Soroka Medical Center. It will include patients who suffer from AMI, patients with CKD with and without any cardiac disease and patients with no known renal or cardiac disease. The study population will be enrolled according to the above inclusion and exclusion criteria.
Who may be able to join
- Patients who are able to give informed consent.
- Age ≥ 18
Who cannot join
- Pregnant women
- Patients after kidney transplantation.
- Patients after heart transplantation.
- Anuric patients.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, in order to better understand the mechanism of troponin clearance and the reason for elevated troponin levels in patients with CKD, we aim to evaluate quantitatively the excretion of troponin in the urine in patients with and without CKD, and with and without myocardial injury. We will compare urinary troponin levels with blood troponin levels in these patients. In addition, we will compare the levels of hs-cTnT and hs-cTnI in the patients' sera and urine.
Read the detailed description
The study population will be screened at the internal wards, the nephrology ward and clinic, and the intensive cardiac care unit (ICCU) of Soroka Medical Center. It will include patients who suffer from AMI, patients with CKD with and without any cardiac disease and patients with no known renal or cardiac disease.
The following information and measurements will be collected:
Demographics - age, sex, weight, height. Past medical history - specifically regarding renal and cardiac diseases and procedures.
Measured variables in blood serum - troponin T, troponin I, creatinine, total protein, albumin, myoglobin Measured variables in urine - troponin T, troponin I, creatinine, total protein, albumin, microalbumin, β2-microglobulin Calculations - GFR (according to MDRD equation), troponin correction to creatinine (gr troponin per gr creatinine), troponin excretion ( ), urine albumin/creatinine ratio, urine protein/creatinine ratio.
- Being tested
- Blood and urine sampling
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine samplingDiagnostic test
- Blood tests - hs-cTnT, hs-cTnI, complete metabolic panel including urea, creatinine, albumin and myoglobin
- Urine tests - hs-cTnT, hs-cTnI, urea, creatinine, albumin, total protein, β2-microglobulin.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Healthy subjects without any evidence of cardiac o | Inclusion criteria:
1. Normal serum troponin (below the 99th percentile)
2. GFR 60ml/min
3. Proteinuria <1gr/gr creatinine
Blood and urine samples will be collected for troponin and other measures. Receives: Diagnostic Test: Blood and urine sampling | |
| Group 2 - Subjects with acute myocardial infarction and norm | Inclusion criteria:
1. At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels.
2. GFR 60ml/min/1.73m2
Blood and urine samples will be collected for troponin and other measures. Receives: Diagnostic Test: Blood and urine sampling | |
| Group 3 - Subjects with acute myocardial infarction and decr | Inclusion criteria - Group 3a:
1. At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels.
2. 30 GFR <60ml/min/1.73m2
Inclusion criteria - Group 3b:
3. At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels.
4. GFR <30ml/min/1.73m2
Blood and urine samples will be collected for troponin and other measures. Receives: Diagnostic Test: Blood and urine sampling | |
| Group 4 - Subjects with decreased GFR but without any eviden | Inclusion criteria - Group 4a:
1. Normal serum troponin (below the 99th percentile)
2. No known past medical history of any cardiac disease and/or procedure.
3. 30 GFR <60ml/min/1.73m2
Inclusion criteria - Group 4b:
4. Normal serum troponin (below the 99th percentile)
5. No known past medical history of any cardiac disease and/or procedure.
6. GFR <30ml/min/1.73m2
Blood and urine samples will be collected for troponin and other measures. Receives: Diagnostic Test: Blood and urine sampling | |
| Group 5 - Subjects with chronic myocardial injury and normal | Inclusion criteria:
1. At least one measurements of serum troponin above the 99th percentile, with neither a rise nor fall in cardiac troponin levels.
2. GFR 60ml/min/1.73m2
Blood and urine samples will be collected for troponin and other measures. Receives: Diagnostic Test: Blood and urine sampling | |
| Group 6 - patients on RRT | Inclusion criteria:
a. Patients who are dependent on renal replacement therapy, including hemodialysis, peritoneal or hemodiafiltration.
Blood and urine samples will be collected for troponin and other measures. Receives: Diagnostic Test: Blood and urine sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin T in blood vs. urine
Quantitative measurements of hs-cTnT in blood and urine
Measured: 1 year
Troponin I in blood vs. urine
Quantitative measurements of hs-cTnI in blood and urine
Measured: 1 year
Secondary outcomes (3)
Troponin excretion in urine compared to creatinine
Comparing urine troponin levels to urine creatinine, albumin, β2-microglobulin
Measured: 1 year
Troponin excretion in urine compared to albumin
Comparing urine troponin levels to urine albumin
Measured: 1 year
Troponin excretion in urine compared to β2-microglobulin
Comparing urine troponin levels to urine β2-microglobulin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 131 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmeen Abu Fraiha, Soroka University Medical Center
- Investigators
- Yosef Haviv, MD, Study chair, Soroka UMC, Nephrology Department, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211610
- Sponsor's protocol ID
- 0234-19-SOR
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2019
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Twerenbold R, Wildi K, Jaeger C, Gimenez MR, Reiter M, Reichlin T, Walukiewicz A, Gugala M, Krivoshei L, Marti N, Moreno Weidmann Z, Hillinger P, Puelacher C, Rentsch K, Honegger U, Schumacher C, Zurbriggen F, Freese M, Stelzig C, Campodarve I, Bassetti S, Osswald S, Mueller C. Optimal Cutoff Levels of More Sensitive Cardiac Troponin Assays for the Early Diagnosis of Myocardial Infarction in Patients With Renal Dysfunction. Circulation. 2015 Jun 9;131(23):2041-50. doi: 10.1161/CIRCULATIONAHA.114.014245. Epub 2015 May 6.
PubMed 25948542Freda BJ, Tang WH, Van Lente F, Peacock WF, Francis GS. Cardiac troponins in renal insufficiency: review and clinical implications. J Am Coll Cardiol. 2002 Dec 18;40(12):2065-71. doi: 10.1016/s0735-1097(02)02608-6.
PubMed 12505215Kanderian AS, Francis GS. Cardiac troponins and chronic kidney disease. Kidney Int. 2006 Apr;69(7):1112-4. doi: 10.1038/sj.ki.5000174.
PubMed 16531987Ziebig R, Lun A, Hocher B, Priem F, Altermann C, Asmus G, Kern H, Krause R, Lorenz B, Mobes R, Sinha P. Renal elimination of troponin T and troponin I. Clin Chem. 2003 Jul;49(7):1191-3. doi: 10.1373/49.7.1191. No abstract available.
PubMed 12816921Petra, P., Tomo, S., Ingrid, P., Jurica, V., Andrea, R., & Sonja, P. Urine Concentrations of High-Sensitivity Cardiac Troponin I in Healthy Adults - Preliminary Reference Intervals. Acta Med Croatica , 461-465, 2018
Petra, P., Tomo, S., Ingrid, P., Ana, S., Matija, B., & Sonja, P. Urine High-Sensitive Troponin I Measuring in Patients with Hypertension. Signa Vitae , 13(SUPPL 3): 62-64, 2017
Friden V, Starnberg K, Muslimovic A, Ricksten SE, Bjurman C, Forsgard N, Wickman A, Hammarsten O. Clearance of cardiac troponin T with and without kidney function. Clin Biochem. 2017 Jun;50(9):468-474. doi: 10.1016/j.clinbiochem.2017.02.007. Epub 2017 Feb 11.
PubMed 28193484Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Glob Heart. 2018 Dec;13(4):305-338. doi: 10.1016/j.gheart.2018.08.004. Epub 2018 Aug 25. No abstract available.
PubMed 30154043Dubin RF, Li Y, He J, Jaar BG, Kallem R, Lash JP, Makos G, Rosas SE, Soliman EZ, Townsend RR, Yang W, Go AS, Keane M, Defilippi C, Mishra R, Wolf M, Shlipak MG; CRIC Study Investigators. Predictors of high sensitivity cardiac troponin T in chronic kidney disease patients: a cross-sectional study in the chronic renal insufficiency cohort (CRIC). BMC Nephrol. 2013 Oct 22;14:229. doi: 10.1186/1471-2369-14-229.
PubMed 24148285
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Troponin Excretion in Urine in Patients With and Without Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04211610
- Acronym / sponsor ID
- 0234-19-SOR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, in order to better understand the mechanism of troponin clearance and the reason for elevated troponin levels in patients with CKD, we aim to evaluate quantitatively the excretion of troponin in the urine in patients with and without CKD, and with and without myocardial injury. We will compare urinary troponin levels with blood troponin levels in these patients. In addition, we will compare the levels of hs-cTnT and hs-cTnI in the patients' sera and urine.
Detailed description
The study population will be screened at the internal wards, the nephrology ward and clinic, and the intensive cardiac care unit (ICCU) of Soroka Medical Center. It will include patients who suffer from AMI, patients with CKD with and without any cardiac disease and patients with no known renal or cardiac disease.
The following information and measurements will be collected:
Demographics - age, sex, weight, height. Past medical history - specifically regarding renal and cardiac diseases and procedures.
Measured variables in blood serum - troponin T, troponin I, creatinine, total protein, albumin, myoglobin Measured variables in urine - troponin T, troponin I, creatinine, total protein, albumin, microalbumin, β2-microglobulin Calculations - GFR (according to MDRD equation), troponin correction to creatinine (gr troponin per gr creatinine), troponin excretion ( ), urine albumin/creatinine ratio, urine protein/creatinine ratio.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Healthy subjects without any evidence of cardiac o | – | Diagnostic Test: Blood and urine samplingInclusion criteria: 1. Normal serum troponin (below the 99th percentile) 2. GFR 60ml/min 3. Proteinuria <1gr/gr creatinine Blood and urine samples will be collected for troponin and other measures. |
| Group 2 - Subjects with acute myocardial infarction and norm | – | Diagnostic Test: Blood and urine samplingInclusion criteria: 1. At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels. 2. GFR 60ml/min/1.73m2 Blood and urine samples will be collected for troponin and other measures. |
| Group 3 - Subjects with acute myocardial infarction and decr | – | Diagnostic Test: Blood and urine samplingInclusion criteria - Group 3a: 1. At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels. 2. 30 GFR <60ml/min/1.73m2 Inclusion criteria - Group 3b: 3. At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels. 4. GFR <30ml/min/1.73m2 Blood and urine samples will be collected for troponin and other measures. |
| Group 4 - Subjects with decreased GFR but without any eviden | – | Diagnostic Test: Blood and urine samplingInclusion criteria - Group 4a: 1. Normal serum troponin (below the 99th percentile) 2. No known past medical history of any cardiac disease and/or procedure. 3. 30 GFR <60ml/min/1.73m2 Inclusion criteria - Group 4b: 4. Normal serum troponin (below the 99th percentile) 5. No known past medical history of any cardiac disease and/or procedure. 6. GFR <30ml/min/1.73m2 Blood and urine samples will be collected for troponin and other measures. |
| Group 5 - Subjects with chronic myocardial injury and normal | – | Diagnostic Test: Blood and urine samplingInclusion criteria: 1. At least one measurements of serum troponin above the 99th percentile, with neither a rise nor fall in cardiac troponin levels. 2. GFR 60ml/min/1.73m2 Blood and urine samples will be collected for troponin and other measures. |
| Group 6 - patients on RRT | – | Diagnostic Test: Blood and urine samplingInclusion criteria: a. Patients who are dependent on renal replacement therapy, including hemodialysis, peritoneal or hemodiafiltration. Blood and urine samples will be collected for troponin and other measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be screened at the internal wards, the nephrology ward and clinic, and the intensive cardiac care unit (ICCU) of Soroka Medical Center. It will include patients who suffer from AMI, patients with CKD with and without any cardiac disease and patients with no known renal or cardiac disease. The study population will be enrolled according to the above inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Patients who are able to give informed consent.
- Age ≥ 18
Key exclusion criteria (4 listed)
- Pregnant women
- Patients after kidney transplantation.
- Patients after heart transplantation.
- Anuric patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine sampling* Blood tests - hs-cTnT, hs-cTnI, complete metabolic panel including urea, creatinine, albumin and myoglobin * Urine tests - hs-cTnT, hs-cTnI, urea, creatinine, albumin, total protein, β2-microglobulin. | Diagnostic test | Group 1 - Healthy subjects without any evidence of cardiac o, Group 2 - Subjects with acute myocardial infarction and norm, Group 3 - Subjects with acute myocardial infarction and decr, Group 4 - Subjects with decreased GFR but without any eviden, Group 5 - Subjects with chronic myocardial injury and normal, Group 6 - patients on RRT |
Primary outcome
Troponin T in blood vs. urine
Time frame: 1 year
Quantitative measurements of hs-cTnT in blood and urine
Troponin I in blood vs. urine
Time frame: 1 year
Quantitative measurements of hs-cTnI in blood and urine
3 secondary outcomes
Troponin excretion in urine compared to creatinine
Time frame: 1 year
Troponin excretion in urine compared to albumin
Time frame: 1 year
Troponin excretion in urine compared to β2-microglobulin
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 25948542Twerenbold R, Wildi K, Jaeger C, Gimenez MR, Reiter M, Reichlin T, Walukiewicz A, Gugala M, Krivoshei L, Marti N, Moreno Weidmann Z, Hillinger P, Puelacher C, Rentsch K, Honegger U, Schumacher C, Zurbriggen F, Freese M, Stelzig C, Campodarve I, Bassetti S, Osswald S, Mueller C. Optimal Cutoff Levels of More Sensitive Cardiac Troponin Assays for the Early Diagnosis of Myocardial Infarction in Patients With Renal Dysfunction. Circulation. 2015 Jun 9;131(23):2041-50. doi: 10.1161/CIRCULATIONAHA.114.014245. Epub 2015 May 6.
- Background: PubMed 12505215Freda BJ, Tang WH, Van Lente F, Peacock WF, Francis GS. Cardiac troponins in renal insufficiency: review and clinical implications. J Am Coll Cardiol. 2002 Dec 18;40(12):2065-71. doi: 10.1016/s0735-1097(02)02608-6.
- Background: PubMed 16531987Kanderian AS, Francis GS. Cardiac troponins and chronic kidney disease. Kidney Int. 2006 Apr;69(7):1112-4. doi: 10.1038/sj.ki.5000174.
- Background: PubMed 12816921Ziebig R, Lun A, Hocher B, Priem F, Altermann C, Asmus G, Kern H, Krause R, Lorenz B, Mobes R, Sinha P. Renal elimination of troponin T and troponin I. Clin Chem. 2003 Jul;49(7):1191-3. doi: 10.1373/49.7.1191. No abstract available.
- BackgroundPetra, P., Tomo, S., Ingrid, P., Jurica, V., Andrea, R., & Sonja, P. Urine Concentrations of High-Sensitivity Cardiac Troponin I in Healthy Adults - Preliminary Reference Intervals. Acta Med Croatica , 461-465, 2018
- BackgroundPetra, P., Tomo, S., Ingrid, P., Ana, S., Matija, B., & Sonja, P. Urine High-Sensitive Troponin I Measuring in Patients with Hypertension. Signa Vitae , 13(SUPPL 3): 62-64, 2017
- Background: PubMed 28193484Friden V, Starnberg K, Muslimovic A, Ricksten SE, Bjurman C, Forsgard N, Wickman A, Hammarsten O. Clearance of cardiac troponin T with and without kidney function. Clin Biochem. 2017 Jun;50(9):468-474. doi: 10.1016/j.clinbiochem.2017.02.007. Epub 2017 Feb 11.
- Background: PubMed 30154043Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Glob Heart. 2018 Dec;13(4):305-338. doi: 10.1016/j.gheart.2018.08.004. Epub 2018 Aug 25. No abstract available.
- Background: PubMed 24148285Dubin RF, Li Y, He J, Jaar BG, Kallem R, Lash JP, Makos G, Rosas SE, Soliman EZ, Townsend RR, Yang W, Go AS, Keane M, Defilippi C, Mishra R, Wolf M, Shlipak MG; CRIC Study Investigators. Predictors of high sensitivity cardiac troponin T in chronic kidney disease patients: a cross-sectional study in the chronic renal insufficiency cohort (CRIC). BMC Nephrol. 2013 Oct 22;14:229. doi: 10.1186/1471-2369-14-229.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yosef Haviv, MD study chair
Soroka UMC, Nephrology Department, Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Acute Myocardial Infarction, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin T in blood vs. urine (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211610, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.